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Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model

NCT07503405 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-03-31

No results posted yet for this study

Summary

This will be a randomized, double-blind, placebo-controlled proof of concept study to evaluate the prophylactic efficacy and safety of orally administered TRX-100 in healthy adults challenged with influenza A/France/759/2021 (H1N1) virus.

Conditions

Interventions

DRUG

TRX-100

A single oral dose in capsules

DRUG

Placebo

A single oral dose in capsules

BIOLOGICAL

Influenza A/France/759/2021 (H1N1) virus

A single dose of challenge agent will be delivered Intranasal

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-11-30
Completion
2027-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503405 on ClinicalTrials.gov